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Precision for Medicine is a clinical research organization (CRO) that combines advanced technologies, scientific expertise, and operational scale to accelerate the development of life-changing therapies. The company specializes in oncology and rare disease clinical trials, integrating clinical trial execution with deep scientific knowledge, laboratory expertise, and advanced data sciences.
The Clinical Trial Manager serves as the clinical trial lead responsible for planning, conducting, and overseeing the operational execution of clinical studies in accordance with protocol, SOPs, ICH-GCP guidelines, and all applicable regulatory requirements.
Key responsibilities include:
- Serve as primary clinical point of contact with clients
- Develop study-related clinical documents (clinical plans, ICF templates, study-specific forms, CRF guidelines, training materials)
- Identify and develop training needs for CRAs and third-party vendors; present at Investigator Meetings and Study Kick-off meetings
- Generate potential site lists and drive the site feasibility process
- Develop country-specific recruitment and retention strategies
- Lead internal clinical team meetings and set expectations for CRAs and CTAs
- Oversee submissions and approvals to Competent Authorities and IRB/Ethics Committees
- Develop clinical monitoring strategies to ensure study timelines and quality deliverables
- Generate and utilize metric reporting (CTMS, DM Query Trends, monitoring reports) to track study progress
- Manage eTMF implementation and oversight
- Collaborate on Corrective and Preventative Action Plans (CAPA) development and implementation
- Assist sites and staff with GCP audit preparation
- Manage investigational product processes including drug accountability and reconciliation
- Collaborate with data management on data quality and compliance
- Support business development and marketing activities as appropriate
- May negotiate site budgets and investigator contracts
- May manage clinical vendors (labs, IP, patient diary, home health care)
- May perform clinical data review and query generation
- May have line management responsibilities for supervised staff
Requirements:
- Bachelor's degree or equivalent combination of education and experience in science or health-related field (advanced degree preferred)
- Minimum 5–8 years of clinical research experience with significant clinical monitoring experience
- Experience in Phase 1 FIH (First-in-Human) and healthy volunteer clinical trials
- Mandarin language proficiency required to support Mandarin-speaking clients
- Proficiency with Microsoft Office Products (Outlook, Word, Excel, PowerPoint)
- Excellent communication and interpersonal skills
- Excellent organizational skills, attention to detail, and customer service demeanor
- Ability to travel domestically and internationally including overnight stays
- Must be legally authorized to work in the country of employment without employer sponsorship
